FDA关于临床一期用药的GMP要求，求讨论

乌江鱼0108

FDA发布的这个临床一期用药的GMP生产规范比商业化生产的GMP要求要简单一些，是否是认为一期临床用药的生产只需要遵循这个规范就行了，不需要执行严格的、全面的GMP法规。请大家提出自己的看法，谢谢。

汉字太少

你的附件我不认识

乌江鱼0108

中国临床阶段用药的生产有专门的GMP法规吗？注意不是正式上市的产品。

一沙一叶

乌江鱼0108 发表于 2016-4-28 16:44
中国临床阶段用药的生产有专门的GMP法规吗？注意不是正式上市的产品。

没有，只是在符合GMP的条件下

beiwei5du

一沙一叶 发表于 2016-4-28 20:30
没有，只是在符合GMP的条件下

制剂的临床1,2,3其使用的API是否必须在GMP条件下生产（是必须从GMP厂家采购）嘛？？？非常感谢！

补充内容 (2017-10-8 17:09):
参照Q7A drug subsances for clinical trail

lingzhi

谢谢分享呀

jackieustc

就这个，我也读不懂做到什么程度

beiwei5du

在part 210.2中已经在2008年的修订中将临床1期排除在外了，一期临床仅仅需要遵循这个GMP即可。注意针对于前期已经经过phase 2，phase 3或者商业化生产后，若在进行phase 1的药品生产，则必须遵循part 211。但是不知道什么情况下会存在反过去做临床一期呢？？？？？？
§210.2   Applicability of current good manufacturing practice regulations.

(a) The regulations in this part and in parts 211, 225, and 226 of this chapter as they may pertain to a drug; in parts 600 through 680 of this chapter as they may pertain to a biological product for human use; and in part 1271 of this chapter as they are applicable to a human cell, tissue, or cellular or tissue-based product (HCT/P) that is a drug (subject to review under an application submitted under section 505 of the act or under a biological product license application under section 351 of the Public Health Service Act); shall be considered to supplement, not supersede, each other, unless the regulations explicitly provide otherwise. In the event of a conflict between applicable regulations in this part and in other parts of this chapter, the regulation specifically applicable to the drug product in question shall supersede the more general.

(b) If a person engages in only some operations subject to the regulations in this part, in parts 211, 225, and 226 of this chapter, in parts 600 through 680 of this chapter, and in part 1271 of this chapter, and not in others, that person need only comply with those regulations applicable to the operations in which he or she is engaged.

(c) An investigational drug for use in a phase 1 study, as described in §312.21(a) of this chapter, is subject to the statutory requirements set forth in 21 U.S.C. 351(a)(2)(B). The production of such drug is exempt from compliance with the regulations in part 211 of this chapter. However, this exemption does not apply to an investigational drug for use in a phase 1 study once the investigational drug has been made available for use by or for the sponsor in a phase 2 or phase 3 study, as described in §312.21(b) and (c) of this chapter, or the drug has been lawfully marketed. If the investigational drug has been made available in a phase 2 or phase 3 study or the drug has been lawfully marketed, the drug for use in the phase 1 study must comply with part 211.

[69 FR 29828, May 25, 2004, as amended at 73 FR 40462, July 15, 2008; 74 FR 65431, Dec. 10, 2009]

beiwei5du

附上当年的关于一期临床GMP的相关的讨论稿。
https://www.fda.gov/ohrms/dockets/98fr/oc07114.pdf